Most Read Articles
Pearl Toh, 31 Dec 2019
Adding the neuraminidase inhibitor oseltamivir to usual care speeds up recovery from influenza-like illness by a day compared with usual care alone, with even greater benefits seen in older, sicker patients with comorbidities, according to the ALIC4E study.
Roshini Claire Anthony, 19 hours ago

The presence of pulmonary arterial hypertension (PAH) in individuals with systemic sclerosis is associated with an increased mortality risk, a study from Singapore showed.

23 Dec 2019
At a Menarini-sponsored symposium held during the Asian Pacific Society Congress, renowned cardiologist Prof John Camm provided the latest evidence for chronic stable angina with or without concomitant diseases, with a special focus on the antianginal agent ranolazine and combination therapies. The event was chaired and moderated by Dr Dante Morales from the University of the Philippines College of Medicine.
09 Jan 2020
Acute ischaemic stroke patients who are current or recent smokers are at greater odds of having unfavourable functional outcomes 3 months after the index event, a study has found.

Original New Drug Application Approvals by US FDA (01 - 15 January 2020)

15 Jan 2020
New drug applications approved by US FDA as of 01 - 15 January 2020 which includes New Molecular Entities (NMEs) and new biologics. It does not include Tentative Approvals. Supplemental approvals may have occurred since the original approval date.

AYVAKIT
  • Active Ingredient(s): Avapritinib
  • Strength: 100 mg; 200 mg; 300 mg
  • Dosage Form(s) / Route(s): Tablet; oral
  • Company: Blueprint Medicines Corp
  • Approval Date: 09 January 2020
  • Submission Classification: Type 1 - New Molecular Entity
  • Indication(s): Indicated for the treatment of adults with unresectable or metastatic gastrointestinal stromal tumor (GIST) harboring a platelet-derived growth factor receptor alpha (PDGFRA) exon 18 mutation, including PDGFRA D842V mutations.
  • Approved Label09 January 2020 (PDF)

VALTOCO
  • Active Ingredient(s): Diazepam
  • Strength: 5 mg; 7.5 mg; 10 mg
  • Dosage Form(s) / Route(s): Spray; nasal
  • Company: Neurelis, Inc.
  • Approval Date: 10 January 2020
  • Submission Classification: Type 3 - New Dosage Form
  • Indication(s): Indicated for the acute treatment of intermittent, stereotypic episodes of frequent seizure activity (i.e., seizure clusters, acute repetitive seizures) that are distinct from a patient's usual seizure pattern in patients with epilepsy 6 years of age and older.
  • Approved Label10 January 2020 (PDF)

NUMBRINO
  • Active Ingredient(s): Cocaine hydrochloride
  • Strength: 40 mg/mL
  • Dosage Form(s) / Route(s): Solution; nasal
  • Company: Cody Laboratories, Inc.
  • Approval Date: 10 January 2020
  • Submission Classification: Type 7 - Drug Already Marketed without Approved NDA
  • Indication(s): Indicated for the introduction of local anesthesia of the mucous membranes for diagnostic procedures and surgeries on or through the nasal cavities of adults.
  • Approved Label10 January 2020 (PDF)
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Most Read Articles
Pearl Toh, 31 Dec 2019
Adding the neuraminidase inhibitor oseltamivir to usual care speeds up recovery from influenza-like illness by a day compared with usual care alone, with even greater benefits seen in older, sicker patients with comorbidities, according to the ALIC4E study.
Roshini Claire Anthony, 19 hours ago

The presence of pulmonary arterial hypertension (PAH) in individuals with systemic sclerosis is associated with an increased mortality risk, a study from Singapore showed.

23 Dec 2019
At a Menarini-sponsored symposium held during the Asian Pacific Society Congress, renowned cardiologist Prof John Camm provided the latest evidence for chronic stable angina with or without concomitant diseases, with a special focus on the antianginal agent ranolazine and combination therapies. The event was chaired and moderated by Dr Dante Morales from the University of the Philippines College of Medicine.
09 Jan 2020
Acute ischaemic stroke patients who are current or recent smokers are at greater odds of having unfavourable functional outcomes 3 months after the index event, a study has found.